Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
研究概览
简要总结
Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
For the treatment group, the aromatherapy tablets will be activated for max aromatherapy. For the control group, the tablets will not be activated and will be devoid of scent. For both groups, the tablet will be wrapped in masking tape to maintain the blind for subjects.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18-85 years old
- •Scheduled for one of the following procedures on the day of consent:
- •Epidural steroid injection (ESI)
- •Medial branch block (MBB)
- •Radiofrequency ablation (RFA)
- •Able to provide informed consent
排除标准
- •History of anxiety disorder
- •Currently on anxiolytic therapy
- •Poor sense of smell
- •Allergy/aversion to aromatherapy
- •Non-English speaking
结局指标
主要结局
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
时间窗: Administered within 30 minutes before and 30 minutes after intervention
The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.
次要结局
- Number of Vasovagal Events during Standard of Care Spine Procedure(Assessed within 30 minutes following the standard of care spine procedure)
- Number of Aborted Standard of Care Spine Procedures(Assessed within 30 minutes following standard of care spine procedure completion or abortion)